BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IP-EC-VIDEO-EXT

    MDR report key: 19769462 · Received July 18, 2024

    Report

    Report Number
    9612330-2024-00039
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    July 11, 2024
    Report Date
    January 30, 2025
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    OMB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). ON AUG 26, 2024 - THE IP PTZ ERGOJUST VIDEO EXTENSION WAS RECEIVED INHOUSE. AWAITING INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). INSTALL DATE : (B)(6) 2021. PICTURES AND THE CUSTOMER'S RESPONSE TO QUESTIONNAIRE WERE RECEIVED. A BRACKET WAS ATTACHED TO THE AFFECTED PART IN JANUARY 2024. RISK REVIEW: PER (B)(4) REV 71 XLTEK EEG PSG RAS. HAZARD ID (B)(4). CAUSE - DUE TO MECHANICAL STRESS OR IMPACT, DYNAMIC LOADING, VIBRATION, OR ENVIRONMENTAL CONDITIONS -- ACCESSORY SHELF ON CART MAY BE UNABLE TO SUPPORT THE MASS OF ACCESSORIES OR ITEMS PLACED ON ITS SURFACE, CAUSING IT TO BEND OR BREAK AND LEAVE SHARP EDGES EXPOSED OR BROKEN SUPPORT SYSTEM COULD LAND ON AND HARM SOMEONE. EFFECT (HARM)- CRUSHING INJURY. RBA RATING- MEDIUM. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 002 REF NATUS COMPLAINT#(B)(4). THE AFFECTED PART WAS RETURNED AND ENGINEERING CONDUCTED THE INVESTIGATION. THE FOLLOWING RESULTS WERE DOCUMENTED: INVESTIGATION RESULTS: ONE VIDEO EXTENSION HAD AN ISSUE WITH BOTH INNER WELDS BROKEN. THE CART HAD THE FCA BRACKET INSTALLED AND IT APPEARS IT IS AN OLDER PRE-FCA MAST WITHOUT THE ADDITION OF THE HOOKS TO PREVENT THE MAST FROM FALLING. THE USER NOTICED THE MAST WOBBLING AND TOOK IT OUT OF SERVICE. ROOT CAUSE/PROBABLE ROOT CAUSE: WELDS FAILED DUE TO UNKNOWN CAUSE, COULD BE MISUSE. RECOMMENDED ACTIONS: MONITOR FOR SIMILAR INCIDENTS, THE ADDITION OF THE FCA BRACKET PREVENTED THE MAST FROM FAILING CATASTROPHICALLY. INVESTIGATOR COMPLETION DATE: (B)(6) 2024.

    Description of Event or Problem · 0

    IP PTZ ERGOJUST VIDEO EXTENSION - CUSTOMER REPORTED ERGOJUST CART IS BENDING OVER EVEN AFTER BRACING IT. NO INJURIES.

    Description of Event or Problem · 0

    IP PTZ ERGOJUST VIDEO EXTENSION - CUSTOMER REPORTED ERGOJUST CART IS BENDING OVER EVEN AFTER BRACING IT. NO INJURIES.

    Description of Event or Problem · 0

    IP PTZ ERGOJUST VIDEO EXTENSION - CUSTOMER REPORTED ERGOJUST CART IS BENDING OVER EVEN AFTER BRACING IT. NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148226 IP-EC-VIDEO-EXT IP-EC-VIDEO-EXT OMB NATUS MEDICAL INCORPORATED IP-EC-VIDEO-EXT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown